CHECKLIST

Form Name: Form MD-22

Category: MD
FRESH

Section no. Checklist Name Is Mandatory

1.0 Covering Letter, Yes

Details on Phase of the study
2.0 (pilot/pivotal/postmarketing clinical Yes
investigation),
Whether this study is a global clinical
3.0 investigation if yes, Number of sites and Yes
patients as well as justification for
undertaking such clinical investigation
in India,
Design analysis data as per Table 1 of
4.0 No
schedule VII,
Design input and design output
4.1 Yes
documents,

4.2 Mechanical and electrical tests, Yes

4.3 Reliability tests, Yes

Validation of software relating to the

4.4 Yes
function of the device,

4.5 Any performance test, Yes

4.6 Ex vivo tests, Yes

Biocompatibility and Animal

5.0 performance study for Investigational Yes
medical device as per Table 2 of
schedule VII,
The agreement between the Sponsor
6.0 and Principal and coordinating Yes
investigator,
7.0 Appropriate Insurance certificate, if any, No

Forms for reporting any adverse event

8.0 Yes
and serious adverse event,
Report of biocompatibility tests along
9.0 with rationale for selecting these tests Yes
including a summary report and
conclusion of the study,

10.0 Results of the risk analysis, Yes

11.0 Animal Performance study data, Yes

Investigators Brochure as per Table 4 of

12.0 Yes
schedule VII,
Clinical Investigational Plan as per Table
13.0 Yes
5 of schedule VII,
Case Report Form as per Table 6 of
14.0 Yes
schedule VII,
Informed Consent Form as per Table 8
15.0 Yes
of schedule VII,
Undertaking by the Investigator as per
16.0 Yes
Table 9 of schedule VII,
Pilot or Pivotal Clinical Investigation
17.0 data, including that carried out in other No
countries (if any),
Regulatory status and Restriction on use
18.0 in other countires (if any) where No
marketed or approved,
19.0 Proposed Instruction for use and labels, Yes

Ethics Committee Approval letter as per

20.0 format prescribed in APPENDIX VIII of Yes
Schedule Y of Drugs and Cosmetics Act
1945,

21.0 Other information, if any, No

22.0 Fees Challan, Yes

23.0 Legal Form, Yes

ENDORSEMENT

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